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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00484263 |
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Date of registration:
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07/06/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non Cystic Fibrosis Bronchiectasis
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Scientific title:
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The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non-cystic Fibrosis Bronchiectasis. |
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Date of first enrolment:
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December 2007 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00484263 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Contacts
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Name:
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Caroline H Nicolson, MPhysio |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Alfred Hospital |
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Name:
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Anne Holland, PhD, BAppSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Alfred Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- diagnosis of bronchiectasis on high resolution computer tomography
- at least 2 respiratory exacerbations per year over the past 2 years
- producing sputum daily
- in a stable clinical state
- over 18 years of age.
Exclusion Criteria:
- cystic fibrosis
- Positive response to hypertonic saline challenge - FEV 1 decreased by = 15%
- FEV 1 = 1L
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bronchiectasis
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Intervention(s)
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Drug: Hypertonic saline 6% -
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Primary Outcome(s)
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Number of pulmonary exacerbations
[Time Frame: One year]
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Secondary Outcome(s)
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- St George Respiratory questionnaire - Leicester Cough Questionnaire - Lung Function Tests
[Time Frame: One year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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